TOI

Apex Court Raps Centre Over Clinical Trials
TNN | Jan 14, 2015, 04.37 AM IST  


NEW DELHI: The Supreme Court on Tuesday directed the Centre to respond what action it intended to take on the parliamentary standing committee’s report on irregularity in clinical trials of cervical cancer vaccine saying that government should be concerned about health of its people.
“It should be the concern of UOI that health of people is preserved. Don’t leave the matter to court. It is for the government to find out a way,” a bench headed by Justice Dipak Misra said adding, “If Parliamentary Committee has done something then it is obligatory for the executive government to take action on the report”.

The court asked the government to file an affidavit stating what procedure should be followed in clinical trial of drugs and who should be held responsible for death or adverse effect on the people who underwent trial.

“File affidavit stating protocol to be followed for getting consent of people to undergo trial and the process to find out what is the effect of vaccination and whose liability is it to pay compensation,” a bench headed by Dipak Misra said.

The bench raised questions on why clinical trials of a cervical cancer vaccine were allowed and why particular states and districts were chosen for the trial.

It directed the states of Gujarat and Telangana, which had granted permission for the trial, to file affidavit on how many people died or suffered side effects due to the trial.

Earlier, the court had summoned the files relating to grant of permission for conducting clinical trial of the vaccine in 2012. It had also directed the Centre to produce all files relating to grant of licence for trial of the vaccine to prevent human papyloma virus (HPV) which causes cervical cancer.

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